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Grant Analysis

Purpose & Target

Core objective: To establish and support programs within academic and research institutions aimed at enhancing research rigor and transparency practices, thereby fostering a culture of high-quality neuroscience research.
Target recipients: Academic and research institutions (departments, inter-departmental entities, or equivalent intra-institutional structures).
Size: No explicit size limits; programs of variable size, focus, and scope are encouraged.
SECTOR-SPECIFIC: Neuroscience research.
Geographic scope: United States.
Key filtering criteria: Must be an institutional entity with demonstrated involvement in neuroscience research relevant to the NINDS mission. The program must not involve clinical trials. Emphasizes sustainable culture change within the institution.
Grant frequency and program context: This is a reissue of a previous funding opportunity (RFA-NS-24-020), indicating a recurring program to address ongoing needs in research quality.

Financial Structure

Total estimated annual funding: $3.5 million.
Anticipated number of awards: At least 5.
Anticipated direct costs per award: Between $150,000 - $800,000 annually, commensurate with the scope of the proposed program.
Currency: USD.
Maximum project period: 3 years.
Cost sharing: Not required.
Eligible costs: Personnel (excluding PD(s)/PI(s)), clerical and administrative staff, participant support costs, consultant costs, equipment, supplies, travel for key persons, and other program-related expenses. All expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
Ineligible costs: Inflationary escalation for recurring costs in out years. The NOFO explicitly states it does not support specific research projects within laboratories, research integrity activities focused on ethics already required, large multi-institutional/field-wide initiatives beyond the applicant institution, or activities supported through other NIH funding mechanisms.

Eligibility Requirements

Organizational Types

Higher Education Institutions: Public/State Controlled, Private
Nonprofits: 501(c)(3) IRS Status, Other
For-Profit Organizations: Small Businesses, Other
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized), Indian/Native American Tribal (Other than Federally Recognized)
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations

Geographic Requirements

Must be a US-based organization.
Foreign organizations are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the 'NIH Grants Policy Statement', are allowed.

Research Focus Requirements

Applicant entity must support or perform neuroscience research that is relevant to the NINDS mission.
The program's goals must include increasing rigor and transparency of neuroscience research performed by investigators within the institution or organization.
Applications proposing multi-institutional, national, or international programs are considered non-responsive.
Applications without a demonstrated relationship with multiple laboratories performing research in the NINDS mission space are considered non-responsive.
Projects proposing clinical trials are not allowed.

Registration and Compliance

Must complete and maintain active registrations with: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.

Application Limitations

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
Duplicate or highly overlapping applications under review at the same time will not be accepted.
A letter of institutional commitment is required. Applications lacking this will not be reviewed.
A Resource Sharing Plan for lessons learned and toolkits is required. Applications lacking required elements will be considered incomplete.

Application Process

Application Submission Timeline

Posted Date: October 31, 2024
Open Date (Earliest Submission Date): September 17, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date (approx. September 17, 2025).
Application Due Date: October 17, 2025 by 5:00 PM local time of applicant organization.
Expiration Date: October 18, 2025.
Earliest Start Date: July 2026.

Submission Platform and Format

Applications must be submitted electronically through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Applicants are encouraged to submit early to allow time for any necessary corrections. Late applications will not be accepted.
Strict adherence to the 'Research (R) Instructions' in the 'How to Apply - Application Guide' and program-specific instructions in this NOFO is required.
Applications are evaluated for completeness, compliance, and responsiveness; incomplete, non-compliant, or nonresponsive applications will not be reviewed.

Required Documentation and Materials

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget, Subaward Budget (if applicable).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: This includes:
- Specific Aims: Briefly describe rationale, goals, and plans for implementing, evaluating, optimizing, and sustaining the program.
- Research Strategy: Organized into Significance, Innovation, and Approach. The Approach section must detail implementation, evaluation, dissemination, scalability, and sustainability plans.
Milestones: A table or chart with key milestones, timeline, and metrics for progress (implementation, evaluation, dissemination, sustainability). Applications lacking this information will be considered incomplete and will not be reviewed.
Letters of Support: A letter of institutional commitment is mandatory. It should come from institutional representatives (e.g., department chairs, deans, provosts) demonstrating tangible support for the program's long-term success. Applications lacking this letter will not be reviewed.
Resource Sharing Plan: Required for lessons learned, evaluation outcomes, and toolkits produced. Must include plans for monitoring and publicizing deliverables. If software is developed, a software dissemination plan is required. Applications without required elements will be considered incomplete.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research is involved (clinical trials are not allowed for this NOFO).

Post-Award Requirements

Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for award closeout.
Recipient institutions must ensure that protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as applicable.

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s).
Evaluation emphasizes feasibility, potential impact, expected outcomes, likelihood of community buy-in, scalability, and sustainability of the program.
Assessments are calibrated based on the proposed resources, goals, and potential scalability of each program.

Significance

The importance of the proposed program in addressing identified challenges related to rigor and transparency within the applicant entity or target scientific cohort.
Justification for the intervention and program scope, including tailoring to the target cohort's needs.
Expected transformation of rigor and transparency practices and the sustainable improvement of research quality.
Clarity regarding which outcomes are expected within the funding period versus long-term goals.
The anticipated scalability of the program and its potential impact on the broader scientific community.
Likelihood of achieving community buy-in and stimulating new/enhanced rigor and transparency practices.
How well the proposed intervention(s) address identified areas of need related to scientific rigor and transparency.

Innovation

Evaluation of technical and/or conceptual innovations such as novel approaches/technologies, unique collaborations, or innovative methods for engaging the scientific community in culture change.
How these innovative aspects will advance program goals and improve culture for enhanced rigor and transparency.

Rigor and Feasibility (Approach)

Soundness and achievability of the proposed approach, including plans to implement, evaluate, optimize, and sustain culture change.
Demonstration of sufficient long-term commitment by the applicant entity and equitable accessibility of resources to the local scientific community.
How well the proposed program fits within the applicant entity's mission and the everyday workflows of the scientific community.
Confirmation that the program targets a scientific cohort performing research relevant to the NINDS mission.
Effectiveness of the evaluation plan throughout and beyond the funding period, including clear, objective, and tangible metrics (must include independently verified outcomes, not just self-reported gains).
Plans for iterative optimization of the program based on evaluation results.
Adequacy of the dissemination plan to educate scientific and research administration communities beyond the applicant entity about lessons learned, including publicizing implementation, evaluation, scalability, and sustainability information.
Ease with which external entities will be able to design similar programs based on disseminated information.
Plans for sustaining the program and any gains in research rigor, transparency practices, culture change, and institutional assistance beyond the funding period.
Clarity, quantitativeness, and appropriateness of milestones for implementation, evaluation, dissemination, and sustainability, including activities extending beyond the funding period.

Investigator(s)

Evaluation of the investigator(s)' demonstrated background, training, and expertise relevant to the proposed work.
Quality of the leadership plan for Multiple Principal Investigator (MPI) applications.

Environment

Assessment of whether institutional resources are appropriate to ensure successful execution.
Effectiveness of the proposed institutional entity in targeting the scientific cohort, coordinating the project, and carrying out activities, including having the authority to implement changes.
Extent to which leadership team members are committed to the proposed activities and the NOFO goal of improving local research culture.
Confirmation that the applicant entity or target scientific cohort supports or performs neuroscience research relevant to the NINDS mission.
Tangible commitment from the institution beyond the applicant entity to the proposed program's goals and activities, including beyond the period of the award.

Additional Review Criteria (Not scored separately)

Protections for Human Subjects (if applicable).
Vertebrate Animals involvement (if applicable).
Biohazards (if applicable).
Authentication of Key Biological and/or Chemical Resources.
Justification for the budget and requested period of support.

Compliance & Special Requirements

Regulatory Compliance

Compliance with '2 CFR Part 200' (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
All awards are subject to the terms and conditions outlined in the 'NIH Grants Policy Statement'.
Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration.
Compliance with all relevant federal statutes and regulations pertaining to federal financial assistance is mandatory.
Mandatory disclosure of violations of federal criminal law (fraud, bribery, or gratuity violations) potentially affecting the federal award (as per '2 CFR 200.113' and 'NIH Grants Policy Statement Section 4.1.35') is required.

Data Protection and Privacy

While the 'NIH Policy for Data Management and Sharing' is generally applicable, a 'Data Management and Sharing Plan' is not applicable for this specific NOFO.
A 'Resource Sharing Plan' for lessons learned, evaluation outcomes, and toolkits produced is required.

Intellectual Property Policies

If proprietary software is developed, it must be reported as a research tool, and the 'NIH Research Tools Guidelines' ('NIH GPS 8.2.3') will apply.
Software source code developed should be well-annotated and freely available to biomedical researchers, administrators, and educators in the non-profit sector.
Users must be permitted to modify the code and share modifications.
The terms of software availability should allow for enhanced or customized versions, or incorporation into other software packages.
The software should be transferable to allow for continued development by others if original developers are unable to continue.

Ethical Standards

Applications involving human subjects or vertebrate animals will be evaluated based on specific criteria for protection and ethical considerations.
This grant does not support research integrity activities focused on ethics related to animal use, human subjects, or research misconduct that are already required under NIH Responsible Conduct of Research (RCR) policies.

Risk Management and Security

Proposed programs must describe potential barriers to success and how they will be addressed.

Unique Aspects

The program places a strong emphasis on achieving 'sustainable culture change' within the applying institutional entity, impacting local scientific communities.
There is an expectation for broad dissemination of program results, lessons learned, and best practices, even for less effective programs, to encourage adoption or modification by other institutions.
Applicants are strongly encouraged to consult with NINDS program staff early during the planning process.

Exclusion Criteria

Applications for specific research projects within laboratories (e.g., reagents, animal housing costs, specialized scientific equipment) are not supported.
Applications for large multi-institutional or field-wide initiatives that extend beyond the applicant institution during the award period are not supported.

Grant Details